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FDA PILOT STUDIES ON MD ADUERSE DRUG REACTION REPORTING WILL BE CONDUCTED, AGENCY SAYS IN ACTION PLAN; EMPHASIS ON NEW TECHNOLOGY SET

Executive Summary

FDA efforts to increase the level of adverse drug reaction reporting by physicians will initially focus on pilot studies to assess the best way to encourage professional reporting, according to FDA's "Plan for Action" released July 26. "A significant shortcoming of the ADR system is underreporting by health professionals," the Action Plan states. "Because direct reports from physicians contain a higher proportion of serious reactions than do those received from industry, increased ADR reporting from U.S. physicians should significantly enhance the usefulness of the ADR system." The agency notes that "approximately 90% of ADR reports to FDA are from industry, and only about 10% are submitted directly by physicians." The Action Plan explains that the physician pilot studies "will entail concerted efforts to promote reporting using innovative means in defined areas. The goal is to improve both the quality and quantitiy of ADR reporting from health professionals" The agency document states that the studies will be designed to: (1) develop educational and promotional interventions aimed at appropriately increasing physician reporting; (2) implement interventions through hospitals and the medical community at large; (3) collect ADR reports and submit these to the FDA; and (4) evaluate the impact of the interventions." The agency points out that physician reporting to FDA has been limited because physicians are not always aware that reporting is important. "Limited surveys suggest that fewer than 10% of physicians are aware of the ADR system and that less than half of these have reporting forms readily available," the Action Plan states. Additionally, it says that "feedback of data to the medical community has been limited, in part, because in the past, generation of reports from the system was so difficult." At a July 26 briefing on the Action Plan, FDA Drugs & Biologics Epidemiology and Bio-statistics Associate Director Gerald Faich, MD, commented that FDA is "looking to build a national surveillance system of physicians reporting directly" to the agency. Faich also addressed FDA's efforts in establishing a system of electronic data submission. "We have in place the computer hardware," Faich said. It now "depends on mfrs. coming up to speed." He also noted that FDA is "looking at laser storage for record retrieval." In a press briefing called one day before issuance of the Action Plan, HHS Secty. Heckler noted that FDA is also "preparing a new regulation which, for the first time, would bring [unapproved] pre-1962 drugs into the post-marketing surveillance system." Heckler also commented on the role of technology with regard to the drug review process. She said FDA will build into the process "an automatic data delivery and transmission capability to permit companies to submit NDAs electronically." ln the past, she stated, "NDAs have been delivered -- literally by truck -- - in some 100 volumes, containing an average 100,000 pages of data." With the new NDA rewrite regulation, she said FDA is "already poised to reduce this load by as much as 70%" and in ther future such data will be transmitted via a cassette. The Action Plan mentions the need for greater FDA attention to the new technologies, specifically biotechnology and microelectronics. With regardto biotechnology, the document states that "product approval alone is insufficient; a system of post-marketing surveillance must also be developed." The plan notes that "it is essential to provide appropriate training for inspectors, specialists for inspection teams, and regulatory consistency within the agency." The document outlines the specific duties of the Special Assistant to the Commissioner for Biotechnology, a new position recently assigned on an acting basis to Mary Ann Danello, PhD, who has been Special Assistant to the Commissioner for Science. According to the Action Plan, the role of the biotechnology assistant will be to "review current programs, identify areas for research, coordinate the advisory system for product approval within FDA, facilitate training of field personnel, and recommend to the commissioner appropriate facilities, equipment and personnel to meet the mission of FDA." In addition, the biotechnology assistant will "coordinate collaborative extramural programs with universities as required." In the area of internal management, the Action Plan notes that a commissioner's advancement program will "serve as an umbrella to advance the careers of employees and the goals of the agency simultaneously" and "become an integral part of the annual planning process of the agency." FDA Deputy Com. Norris said at the briefing on the plan that the agency will "look at any employee that hasn't had advancement in five years" and see what can be done to assist in advancing the individual.

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